tbuckley/cabot-search huggingface dataset:
Impact of death anxiety (DA) on the psychological well-being and survival of patients with advanced cancer (ACP) in phase I trials and their spousal caregivers (SC).
Authors: Fay J. Hlubocky, David Cella, Tamara Sher, Christopher K. Daugherty
Journal: Journal of Clinical Oncology (2023)

e24213 Background: ACP and their SC experience psychological distress living with future uncertainty regarding their cancer. Yet, little is known how existential DA adversely impacts the psychological well-being and overall survival of ACP participating in Phase I trials and their SC. Methods: A prospective study of ACP enrolling in phase I trials and their SC were assessed at baseline (T1) and one month (T2) using quantitative symptom measures including: depression (CES-D), state anxiety (STAI-S), quality of life/qol (FACIT-Pal), and global health (SF-36). Semi-structured interviews evaluated DA: suffering; meaning, and worry re death. Results: To date, 158 participants (79 Phase I ACP and 79 SC) have been separately interviewed at T1 and T2. For the total population: median age 62 (28-79y); 50% male; 100% married; 89% Ca; 69% &gt; HS educ; 59% GI dx; ACP median survival 8.2 month (.51-18.8) 53% income &lt; $65,000 yr. At T1, 83% of ACP experienced worry re death, and 77% reported suffering. For SC at T1, 75% reported worry re ACP death; 88% worried re own death; and 85% reported experiencing suffering and 84% lost meaning during the ACP illness. For both ACP and SC, rates remained consistent for both ACP and SC. At T2, ACP with worry re death had higher STAI-S (32±11 v. 28±9, p = 0.04) and CES-D scores (12±10 v. 11±10, p = 0.03). SC with self-reported suffering had higher STAI-S anxiety (38±15 v. 34±12, p = 0.02) at T2. Regression analyses revealed ACP with worry had worsening FACIT-Pal QOL over time. Also, SC with suffering at T2 was negatively associated with SF-36 scores. Regarding survival, ACP with DA had shorter survival compared to ACP without DA (4.4 v. 6.9 months, p = 0.02). Conclusions: Phase I ACP and SC report worry re death and suffering negatively impacting their psychological well-being and survival. Supportive couple-based, dyadic psychological interventions for ACP-SC designed to address DA coping are needed.
Association of congestive heart failure with hospital outcomes among patients with chronic lymphocytic leukemia in the United States: Analysis of nationwide inpatient sample.
Authors: Rahman Adesoji Olusoji, Abiodun Idowu, Olanrewaju Adabale, Rajaa Mohamed Salih, Ibrahim Omore, Meena Ahluwalia
Journal: Journal of Clinical Oncology (2023)

e19506 Background: Chronic Lymphocytic Leukemia (CLL) is adults' most prevalent chronic leukemia. There is an increased report of cardiovascular comorbidities in these patients due to the multi-systemic impact of both the insidious disease and the associated side effects of its treatment. This study aimed to provide real-world contemporary data on the in-hospital outcomes among patients admitted for CLL with comorbid Congestive Heart Failure (CHF) in the United States. Methods: The study is a retrospective study that used the National Inpatient Sample database. We identified patients hospitalized for CLL from 2018-2020 and stratified them into two cohorts – with CHF and without CHF. Inclusion criteria include age ≥ 18 years and hospitalization primarily for active CLL. We excluded patients with aortic stenosis and those whose CLL were in remission. Inferential statistics - chi-squared test and Student t-test (as applicable) - was done on extracted data. The odds ratio was calculated using univariate and multivariate analyses. All analyses were done at a 95% confidence interval with a 2-tailed p-value &lt;0.05 set as the cut-off for statistical significance. Results: A total of 210,012 hospitalizations of CLL were identified, of which 27.5% (57,650) had comorbid CHF. On univariate logistics regression analysis, the average length of hospitalization was statistically (p&lt;0.001) prolonged by one day, and the cost of hospitalization increased by 9,640 + 1482 US dollars among those with CHF and active CLL. The odds of all-cause in-hospital mortality increased by 1.6 folds in these patients (P&lt;0.001). However, after adjusting for individual patients and hospital-level cofounders, active CLL did not have a significant clinical impact on the duration and total cost of heart failure hospitalization. Active CLL, however, significantly increased the risk of all-cause in-hospital mortality by 1.3 folds (4.7% vs 7.2%; adjusted odds ratio 1.31, 95% CI 1.17-1.46; p&lt;0.01) in patients with heart failure. Conclusions: Patients hospitalized for active CLL with a comorbid diagnosis of CHF have increased odds of in-hospital mortality compared to those without comorbid heart failure. This finding suggests the need for integrative multi-disciplinary care for CLL patients with comorbid CHF, such as cardio-oncology.
First integrative oncology clinic in the Veteran Affairs (VA) Pittsburgh healthcare system.
Authors: Jocelyn L Tan, Hema Rai, Vida Almario Passero, Jeanne Green, James G. Herman, Dana Genovese, Lauri Harrold, Lisa Denk
Journal: Journal of Clinical Oncology (2023)

e24041 Background: Integrative oncology (IO) is PROACTIVE and combines complementary with conventional care. The VA's comprehensive collection of integrative services is already in place. However, providers are often unaware of these, therefore veteran cancer patients don’t benefit from them. Prostate cancer is the most common cancer within the VA (31.8%), Aside from radiation/chemotherapy side effects (dry mouth, stomatitis, fatigue, neuropathy, gastrointestinal ) prostate cancer patients also have hormonal issues (hot flashes, low bone density, sexual dysfunction). Conventional treatments focus on symptoms (REACTIVE). Complementary and IO approaches are evidence-based toward specific treatment-related side effects. By educating and offering integrative approaches, we empower veterans to take charge of their health and well-being. Shifting our focus from treating only the disease to treating the entire patient, will improve health outcomes. Methods: Recruit 40 prostate cancer patients with fatigue, radiation-induced diarrhea, neuropathy, nausea, vomiting, anorexia, constipation, sexual dysfunction, and emotional issues(depression, anxiety, poor sleep, lack of energy). Identify/train providers to focus on concerning areas. Develop VA Personal Health Plans (PHP) to identify patients mission, aspiration, and purpose (MAP). Offer acupuncture, yoga, Reiki, TaiChi, meditation, biofeedback for headaches - Video Support group. Assessment tools. In late 2022, we reached our goal of 40 prostate cancer patients and opened clinic enrollment to patients of all cancer types. Results: The pilot IO clinic began in 2020, with 40 patients. In 2022, we expanded services to patients with other cancer types. Integrative options improved surgical outcomes, minimize chemotherapy /radiation side effects, boost morale, and optimize clinical outcomes. There is a high-interest level among oncology staff and patients. Resources are abundant but need organization and refinement to effectively present IO to our patients. Conclusions: There is huge potential for integrative oncology to improve the clinical, laboratory, and quality-of-life outcomes of cancer patients. We were able to construct a program within the Veteran Affairs, using existing integrative resources with high patient engagement. Currently, we plan to expand services to other VA sites nationwide.
NeoCOAST-2: A phase 2 study of neoadjuvant durvalumab plus novel immunotherapies (IO) and chemotherapy (CT) or MEDI5752 (volrustomig) plus CT, followed by surgery and adjuvant durvalumab plus novel IO or volrustomig alone in patients with resectable non-small-cell lung cancer (NSCLC).
Authors: Florian Guisier, Jaafar Bennouna, Alexander I. Spira, Dong-Wan Kim, Byoung Yong Shim, Houssein Abdul Sater, Italia Grenga, Swapnil S Parmar, Agata A. Bielska, Alula Yohannes, Raymond Mager, Oday Hamid, Lara McGrath, Yun He, Yee Soo-Hoo, Rakesh Kumar, Jonathan Spicer, Patrick M. Forde, Tina Cascone
Journal: Journal of Clinical Oncology (2023)

TPS8604 Background: Neoadjuvant platinum-based CT plus IO prolongs event-free survival (EFS) and increases pathological complete response (pCR) rate in patients with resectable NSCLC vs CT alone (Forde et al. N Engl J Med 2022). IO+IO+CT combinations have the potential to further improve pCR and survival outcomes. The phase 2 NeoCOAST-2 study (NCT05061550) is evaluating multiple neoadjuvant IO+IO+CT combinations in patients with resectable, early stage NSCLC. Novel IO molecules being evaluated include the anti-CD73 monoclonal antibody (mAb), oleclumab; the anti-NKG2A mAb, monalizumab; and the PD-1/CTLA-4 bispecific mAb, volrustomig. The latter recently demonstrated durable responses vs a PD-1 inhibitor plus CT as first-line treatment for patients with metastatic NSCLC (ESMO 2022; LBA56). Here we describe the NeoCOAST-2 study design. Methods: This randomized, open-label, multicenter study will enrol approximately 210 patients with previously untreated, histologically/cytologically confirmed, resectable Stage IIA–IIIB (AJCC 8 th edition) NSCLC. Patients will be stratified by PD-L1 expression ( &lt; 1% vs ≥1%) and receive treatment with durvalumab + oleclumab + CT, durvalumab + monalizumab + CT, or volrustomig + CT every 3 weeks for 4 cycles prior to surgery, followed by adjuvant durvalumab + oleclumab, durvalumab + monalizumab, or volrustomig for up to 1 year or until disease progression per RECIST v1.1. Surgery should occur within 40 days after the last dose of neoadjuvant therapy and adjuvant therapy should commence within 10 weeks after surgery. The primary endpoints are pCR rate (per blinded independent pathologist review) and safety and tolerability. Secondary endpoints include investigator-assessed EFS, disease-free survival and overall survival, feasibility to surgery, major pathological response rate, objective response rate following neoadjuvant therapy, pharmacokinetics, immunogenicity, and changes in circulating tumor DNA. The study is currently recruiting patients across the US, Europe, Canada, and Asia. Clinical trial information: NCT05061550 .
Outcomes of myeloid malignancies in patients previously treated with PARP inhibitors for solid malignancies: A single institution experience.
Authors: Emmanuel Almanza-Huante, Alex Bataller, Samuel Urrutia, Georgina Gener-Ricos, Robert Briski, Rashmi Kanagal-Shamanna, Karen H. Lu, Shannon Neville Westin, Timothy A. Yap, Koichi Takahashi, Farhad Ravandi, Yesid Alvarado Valero, Tapan M. Kadia, Koji Sasaki, Hagop M. Kantarjian, Guillermo Garcia-Manero
Journal: Journal of Clinical Oncology (2023)

e19000 Background: Treatment with Poly(ADP-ribose) Polymerase proteins (PARP) has improved the survival of patients (pts) with solid malignancies harboring a homologous recombination deficiency (HRD). The association between PARP inhibitors (PARPi) and the development of myeloid neoplasms post cytotoxic therapy (MN-pCT) has been reported. We aim to describe the characteristics and outcomes of pts who develop MN-pCT after treatment with PARPi. Methods: Pts treated with PARPi at a single institution from July 2014 to August 2022, who developed MN-pCT (AML, MDS or CMML), were retrospectively evaluated. Diagnosis of MN-pCT was defined according to the 5 th edition of the WHO criteria. Clinical and demographic characteristics along with cytogenetics and molecular features were analyzed. HRD was assessed by NGS on peripheral blood with a 13-gene panel. Results: 1462 pts were treated with PARPi at MDACC. Of these, 15 (1%) developed MN-pCT. These include 9 (60%) with MDS, 5 (34%) with AML, and 1 (7%) with B/Myeloid Mixed-Phenotype Acute Leukemia (MPAL). The median age was 62 (46-74) years and 14 (93%) were female. The most frequently used PARPi was olaparib in 9 (60%) pts. All pts had also previously received platinum-based agents and taxanes. Pts with 19 different solid tumors were included; 11 (85%) had active concomitant solid tumors at the time of MN-pCT. The median time from PARPi treatment to myeloid neoplasm (TTM) was 20.7 months (9.3-39.9). Cytogenetics and molecular features were available in 14 pts (93%). Eight (57%) had complex karyotype. The median number of mutations were 2 (0-4). TP53mut was present in 9 (64%) pts with a median VAF 47.3% (11.9-76.6%) of whom 6 (67%) were biallelic. The ORR to antileukemic therapy was 66% (n = 8): 3 (38%) had CR, 2 (25%) had PR, 2 (25%) had mCR with HI and 1 (13%) had isolated HI. The patient with B/myeloid MPAL was not evaluable for response. Of the responders, 7 (88%) pts relapsed at a median of 2.8 months (1.5-4.2). The median OS and EFS on the whole cohort were 7.8 (3.2-12.4) and 5.3 (3.8-6.7) months respectively. Conclusions: Development of MN-pCT in pts treated with PARPi is rare but most outcomes are very poor. Prospective analysis to evaluate pts at higher risk of developing MN-pCT is warranted in order to select pts who might benefit from novel therapies without increasing the risk of secondary myeloid malignancies. [Table: see text]
Impact of time period of diagnosis, race, and military exposures on the survival of US military veterans with multiple myeloma and/or plasmacytoma.
Authors: Sharmeen Mahmood, Pankaj Gupta, Helen Ma
Journal: Journal of Clinical Oncology (2023)

e20061 Background: The aging veteran population represents a unique demographic with potential exposures to carcinogens. Multiple myeloma has been linked to exposure to Agent Orange, burn pits, radiation, and water contamination. There have been remarkable advances in the management of multiple myeloma. We investigate whether the survival of veterans diagnosed with multiple myeloma and/or plasmacytoma has changed over time. Methods: Using ICD-O criteria we identified 14,026 veterans diagnosed with multiple myeloma and/or plasmacytoma between 1/1/2000 and 12/31/2020 in the national electronic Veterans Administration (VA) medical records. Variables including age and date of diagnosis, race, gender, branch of military service, tobacco use, military exposures, cause of death and survival were analyzed. Patients were subdivided into 4 time periods for analysis based on date of diagnosis: Group 1 (1/1/2000-12/31/2005), Group 2 (1/1/2006-12/31/2010), Group 3 (1/1/2011-12/31/2015), Group 4 (1/1/2016-12/31/2020). Results: Of the 14,026 cases, 98% of patients were male, 58% were white and 28% black; 57% were current or previous tobacco users, 26% were never users. The table summarizes military exposures and causes of death. Median overall survival (OS) for Group 1 was 0.9 years [95% CI, 0.8-1], Group 2 was 2 years [95% CI, 1.8-2.9], Group 3 was 2.8 years [95% CI, 2.6-2.9], and Group 4 was 3.5 years [95% CI, 3.3-3.6]. These differences in OS were statistically significant (p&lt;0.0001). Deaths attributed to myeloma accounted for 67%, 65%, 63%, and 56% of patients in Group 1, 2, 3, and 4, respectively. On multivariable analysis of 6023 cases where selected variables were consistently available, tobacco use, exposure to Agent Orange or burn pits, older age and earlier time period of diagnosis were significantly associated with shorter survival. However, race did not significantly impact survival. Conclusions: In US military veterans diagnosed with multiple myeloma and/or plasmacytoma, survival has significantly improved over the past two decades. Survival was adversely impacted by tobacco use and military exposures, but not impacted by race. Advances in diagnosis, therapies and supportive care may have contributed to the observed improvement in survival over time. Future research should investigate if differences exist in the pathophysiology of malignancies developing in veterans with military exposures, and whether novel treatments can improve their outcomes. [Table: see text]
Quality of pain management in patients with cancer in the outpatient setting.
Authors: Biplov Adhikari, Nistha Shrestha, Smriti Maskey, Vijaya Raj Bhatt
Journal: Journal of Clinical Oncology (2023)

12106 Background: Pain represents a common health issue among patients with cancer. Uncontrolled pain significantly impairs the quality of life, resulting in increased healthcare utilization and costs. We examined the patterns of pain medication prescriptions among patients with cancer pain in the outpatient setting. Methods: We used the National Ambulatory Medical Care Survey (NAMCS), an annually administered survey designed to collect data regarding the use of ambulatory medical services from office-based physicians in the United States. We analyzed NAMCS data from 2005 to 2019 for all types of cancers visits. The primary outcome was prescription of pain medications among patients with cancer pain. We performed multivariate logistic regression to identify factors associated with opioid and non-opioid prescription among patients with cancer pain. Results: We captured a total of 520.8 million outpatient visits from 2005-2019. Breast cancer (18.7%) followed by cancer of the male genital tract (11.0%) represented the highest proportion of patient visits. 4.8% of cancer patients reported pain. Majority (60%) complaining of pain did not receive any pain medications. 14.9% received opioids and 25.1% received nonsteroidal anti-inflammatory drugs, acetaminophen, or adjuvant pain medications. The odds of receiving opioids were 3.4 times higher among 45-65 years vs patients over 75 years. African-Americans had 84% higher odds of receiving opioid prescription compared to white patients. The odds of receiving opioids were 61% lower for privately insured vs patients on Medicare. Patients visiting oncologic care had 2.1 times higher odds of receiving opioids compared to primary care (Table). Conclusions: This is one of the largest drug utilization studies among patients with cancer in outpatient setting, covering half a billion patient visits. A significant proportion of outpatients with cancer who reported pain did not receive a prescription for analgesics suggesting a possibility of undertreatment of pain. Within the limitation of this dataset, undertreatment of pain in outpatients with cancer remains a major unmet patient need. [Table: see text]
Disparities in multiple myeloma: A global perspective on drug toxicity trends.
Authors: Majid Jaberi-Douraki, Xuan Xu, Beth Faiman, Gerald Wyckoff, Jim Riviere, Jack Khouri, Sandra Ann Mazzoni, Remya Ampadi Ramachandran, Nuwan Millagaha Gadara, Mobina Golmohammadi, Louis Williams, Christy Joy Samaras, Jason Neil Valent, Faiz Anwer, Shahzad Raza
Journal: Journal of Clinical Oncology (2023)

8015 Background: The FDA Adverse Event Reporting System (FAERS) is one of the largest pharmacovigilance databases containing information on adverse events (AEs) received from manufacturers, consumers and healthcare professionals. The purpose of this study is to evaluate the global disparities in multiple myeloma (MM) through data mining of FAERS. Methods: We examined AEs associated with FDA-approved MM drugs from 2003-2022 from FAERS and the Medical Dictionary for Regulatory Activities. Patient data were then stratified based on age, sex (F/M) and 6 geographical regions. We evaluated the reporting odds ratio (ROR) combined with a 95% confidence interval for the elevated incidence of AEs. Results: The data curation provided 381,378 patients with information from North America (NA), Europe (EU), Asia (AS), Africa (AF), Oceania (OC) and Latin America &amp; the Caribbean (LA), merged from 129 countries and 27 phenotypic systems and organs categories when the number of AEs happened more than 0.1% of the total. Cardiotoxicities (n=23160) and vascular toxicities (n=26716) were seen more in NA (M) (ROR=1.16±0.02 and EU (M) (ROR=1.11± 0.03) compared to the rest of the World. Nephrotoxicity (n=17486) was reported more in AF (M) (ROR=2.92±0.41) compared to AS (M) (ROR≥1.17± 0.12), EU (M) (ROR≥1.34± 0.13) and NA (M) (ROR=1.09± 0.03). Peripheral neuropathies (n=14786) were frequent among EU (F) (ROR=1.09±0.07) and OC (M) (ROR=1.08± 0.04). Mortality was higher among AS and EU (ROR≥2.15± 0.93) compared to NA and OC. There were 18,222 secondary neoplasms in FAERS. Skin neoplasms (n=4650) more frequently occurred in OC and EU (ROR≥1.70 ±0.16). Breast neoplasms (n=694) were the highest in EU (F) (ROR=4.01+0.63) and lowest in OC (F) (ROR&lt;1). Gastrointestinal neoplasms (n=1564) were more common among AS, EU and OC (M) with (ROR≥2.23±0.47). Lymphomas (n=542) were predominant in AS(M) (ROR=2.21±0.98) and OC (M) (ROR=3.35±2.23). Leukemias (n=3896) cases were significantly higher in EU (M) (ROR=4.08 ± 0.40) and EU (F) (3.11 ± 0.26). Respiratory tract and mediastinal neoplasms (n=796) were more common in AS, EU and OC(M) where ROR≥1.36±0.33. More phenotypic characterization are tabulated below. Conclusions: FAERS can be used to assess cancer disparity from a global perspective. Our results indicates that certain AEs are influenced by gender and geographical location. These disparities in MM AEs may be the result of factors such as genetics, dosing/regimen, comorbidities, age and sex. These variables must be investigated for improved patient care, strategies for AE reduction, mortality reduction and optimal allocation of healthcare resources. [Table: see text]
Racial disparities in utilization of palliative care among inpatients admitted for lung cancer.
Authors: Kavya Bharathidasan, Ashika Ajitkumar, Gaurav Mohan, Shabnam Rehman
Journal: Journal of Clinical Oncology (2023)

e24166 Background: Multiple national database-based studies have shown that Black and Hispanic patients are less likely to receive palliative care options at end-of-life (EOL) inpatient care leading to higher costs and poorer quality of life. To the best of our knowledge, there is no reported data specifically considering lung and pleural malignancies. Methods: We analyzed hospitalizations across the United States in 2019 from the National Inpatient Sample dataset, Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality. We identified adult non-emergent hospitalizations with ‘malignant neoplasm of the lung and bronchus’ (including mesothelioma) listed as the principal reason for hospitalization using the International Classification of Diseases, 10th revision, clinical modification codes C34.0, C34.1, C34.2, C34.3, C34.8, C34.9, and their sub-branches. StataCorp Stata software was used to extract data and compute mortality and palliative care consult utilization among various demographic factors such as sex, age, race, and payer status. Results: Of 67,425 total hospitalizations, 9.4% resulted in mortality. Of these 6338 patients that died, 73.1% were White, 13% Black, 5.8% Hispanic, 3.9% Asians/Pacific Islanders, 0.6% Native Americans, and 3.3% were other races. Palliative care was consulted in 63% of the patients whose admission resulted in death. 64.9% of the White patients, 58.6% of the Black patients, 62.6% of Hispanic patients, 67.7% of Asians/Pacific Islanders, 60% Native Americans, and 59.6% of other races were offered palliative care prior to their death. The average age among the admissions which resulted in death was 69.03 years. Conclusions: While most admissions resulting in mortality were among the White population, there was still a clear discrepancy in the number of Black patients on whom palliative care was consulted. Possible reasons include poor healthcare literacy, physician mistrust, and cultural preferences. Clinicians should consider and suggest early palliative care consultation in the care of Black patients and other minority racial groups to improve the quality of EOL care.